MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH TANGO OPTIMO; AUTOMATED BLOOD BANK ANALYSER SYSTEM

Model Number 848900010

Device Problems False Positive Result (1227); Defective Component (2292); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

This is our combined initial and final report on this incident.

Event Description

The customer reported a discrepant blood group results when using erytype s abd+rev.A1, b on tango optimo.The customer stated that a blood group a rhd positive came out as blood group b rhd positive, possibly caused by carry over.The customer did neither provide the supposedly defective product for investigational testing nor the samples that had caused false positive test results.Therefore our quality control laboratory tested their retention sample of erytype s abd+rev.A1,b with different donor samples on tango optimo.All positive and negative reactions were correct.We did not observe any false positive reactions.Testing by our quality control laboratory confirmed the correct function of the allegedly defective lot of erytype s abd+rev.A1, b.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lot.The customer provided result images.One images shows unexpected positive result interpretation in the anti-b well, which can be visually confirmed.The result was set to invalid and instruments software greys out invalid results.Therefore it is only assumed that the anti-b well does not contain a usual agglutinate.The reaction in other wells does look as expected.Last preventive maintenance for the affected tango optimo was performed on july 02, 2019.A field service engineer checked the instrument.According to the engineer, the rinsing cycle very less frequently #s 3-1-3 , when it should be 3-6-3.He suggested to change to 3-6-3 and run the cleaning cycle 03 times.The customer run clean cycles , qcs and samples, and got all good results.The instrument's left probe was bent to the right and it was outside the clean station center during rinse.It was bent enough to go outside the center of the clean station circle but not far enough to touch anything else or to cause any mechanical error.This means the probe was going down and up completely dry during each rinse cycle outside the clean station center.The probe might be slightly bent while customer performed maintenance by wiping and cleaning the probes, and the issue was fixed by adjusting and aligning the probe to the reference point.The left probe was adjusted and all alignments on the right and left probe were verified.The system performance was within manufacture specification, no carry over have since been reported.The instrument was confirmed to operate within specification by our field service engineer after repair.Because the engineer supposed that the customer might have bent the probe accidently, the customer will be trained to pay attention during maintenance.

• Brand Name: TANGO OPTIMO
• Type of Device: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 8779537
• MDR Text Key: 216216276
• Report Number: 9610824-2019-00032
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969961696
• UDI-Public: (01)07611969961696
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK080013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 848900010
• Device Catalogue Number: 848900010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1